A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT07470879
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
2 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Etrasimod — DRUG
    Once daily by mouth

Study Details

The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \< 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).

Key Dates

First listed
Mar 13, 2026
Start date
May 28, 2026
Status verified
Aug 2026
Primary completion
Sep 8, 2030
Completion
Aug 18, 2034

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Etrasimod
    Etrasimod by mouth, once daily up to 52 weeks

Primary Outcome Measure

Number and percent of enrolled participants with clinical remission based on Modified Mayo Score (MMS) at Week 52 [ Time Frame: Week 52 ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Fink Children's Ambulatory Care CenterNew YorkNew York10016-
Kimmel Pavilion - NYU LangoneNew YorkNew York10016-
NYU Grossman School of MedicineNew YorkNew York10016-
NYU Langone Health (Tisch Hospital)New YorkNew York10016-
NYU Langone Inflammatory Bowel Disease CenterNew YorkNew York10016-
NYU Langone Radiology - Tisch HospitalNew YorkNew York10016-
NYU Medical Science Building (MSB)New YorkNew York10016-

Find similar trials in New York, NY

By research site
Fink Children's Ambulatory Care Center· New York, NYKimmel Pavilion - NYU Langone· New York, NYNYU Grossman School of Medicine· New York, NYNYU Langone Health (Tisch Hospital)· New York, NYNYU Langone Inflammatory Bowel Disease Center· New York, NYNYU Langone Radiology - Tisch Hospital· New York, NY

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